functional coronary angiography guided revascularization in stemi

Conditions: Myocardial Infarction

Summary: the goal of this multicenter randomized clinical trial is to test the superiority in terms of efficacy of the angiography-derived fractional flow reserve (air) over that based on conventional angiography (angio) strategy in the management of non-culprit lesions in stemi patients with multivessel disease. the main questions it aims to answer are: * is an angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite efficacy endpoint of all-cause death, myocardial infarction, cerebrovascular accident, or ischemia-driven revascularization. * is an angiography-derived fractional flow reserve strategy superior to a conventional angiography strategy in reducing the occurrence of the composite safety endpoint of of contrast-associated acute kidney injury and bleeding academic research consortium (barc) type 3-5. participants will be randomized after the successful treatment of the culprit lesion to one of the two strategies and prospectively followed-up.

reperfusion of the culprit lesion through primary pci is the standard of care in st-segment elevation myocardial infarction (stemi) patients, regardless of their age. the actual gold standard for the management of non-culprit lesions in stemi patients with multivessel disease (mvd) is angiography-guided complete revascularization. the complete vs culprit-only revascularization to treat multi-vessel disease after primary pci for stemi (complete) trial randomized 4 041 patients with stemi and mvd. the main finding was the highly significant reduction of new mi occurrence in the complete group (7.9% vs 5.4%, hazard ratio (hr) 0.68, 95% ci 0.53-0.87, p=0.002). revascularization was obtained largely by angiographic evaluation (\>99%). after complete, the subsequent step was to ascertain which complete revascularization strategy should be pursued. in particular, physiology-guided revascularization was compared to an angio-guided strategy. the advantages of physiology against angiography are related to: a) lower number of vessels treated, b) lower number of stents implanted; c) avoidance of a second procedure in negative fractional flow reserve (ffr) patients during primary pci; d) possibility to optimize the procedure from the physiological standpoint after percutaneous coronary intervention (pci). in the flow evaluation to guide revascularization in multivessel st-elevation myocardial infarction (flower-mi), patients with stemi and multivessel disease who had undergone successful pci of the infarct-related artery were randomly assigned to receive complete revascularization guided by either ffr or angiography. the primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. ffr-guided revascularization was associated with lower number of stents implanted per patient (1.01±0.99 versus 1.50±0.86). during follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the ffr-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; p = 0.31). death occurred in 9 patients (1.5%) in the ffr-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. the results of the flower-mi trial may suggest that physiology can provide a similar outcome if compared to a conventional angio-guided approach. however, some limitation should be acknowledged: i) rate of events was three-times lower than expected suggesting both a selection bias and the need of a higher number of patients to demonstrate any difference among the two groups; ii) all patients in the ffr-group received a staged procedure to perform physiology assessment diluting one of the major advantages in ffr negative patients, namely the avoidance of a second procedure if physiology is negative; iii) in 16% of patients in the physio-guided group ffr was not performed before pci, whereas in 82% of patients it was not performed after pci; iv) even if ffr was associated with lower pcis, periprocedural mi was three times higher if compared to the angio-group, suggesting its possible underreporting in the angio-group. after the complete trial2, the actual standard of care in the management of stemi patients with mvd is complete revascularization based on angiography. however, this approach may lead to over- or under-estimation of lesions in a relevant portion of patients with negative impact on prognosis. invasive physiology has been consistently shown to be superior if compared to angio-guided strategy, but it is underutilized in clinical practice mainly due to feasibility issues. a functional coronary angiography could overcome the applicability issues related to invasive physiology. in addition, it is particularly appealing in the evaluation of non-culprit lesions since: 1. it is possible to acquire projection during primary pci and perform the analysis off-line 2. in case of negative assessment, the patient can avoid a second procedure to invasively measure physiology 3. it is possible to optimize most of the procedures by the physiological standpoint through the utilization of the virtual-pci planner tool pre-pci without the need to repeat physiology after pci. 4. it has been recently shown that if compared to an angio-guided approach, angiography-derived ffr was able to reduce the incidence of spontaneous mi by 36% therefore, a strategy based on functional coronary angiography to indicate and guide pci could be superior if compared to an angio-guided strategy both from the efficacy (cv death, cerebrovascular accident, mi and ischemia-driven revascularization) and from the safety (barc 3-5, contrast-associated acute kidney injury) standpoint.

Eligibility criteria:
inclusion criteria: * st-segment elevation myocardial infarction with indication to invasive management * multi-vessel disease defined as at least 1 non-culprit coronary artery lesion at least 2.5 mm in diameter deemed at visual estimation with a diameter stenosis % ranging from 50 to 99% amenable to successful treatment with pci * successful treatment of culprit lesion exclusion criteria: * planned surgical revascularization * left main as non-culprit lesion * non-cardiovascular co-morbidity reducing life expectancy to \< 1 year * any factor precluding 1-year follow-up * prior coronary artery bypass graft (cabg) surgery * impossibility to identify a clear culprit lesion * presence of a chronic total occlusion (cto)

Keywords: percutaneous coronary intervention angiography-derived fractional flow reserve multivessel disease